iGlarLixi治疗2型糖尿病的疗效及安全性的meta分析  

Efficacy and safety of iGlarLixi in the treatment of type 2 diabetes mellitus: a meta-analysis

作　　者：崔智程 鲁一兵[1] 凤心雨 徐家蓉[1] Cui Zhicheng;Lu Yibing;Feng Xinyu;Xu Jiarong(Department of Endocrinology,the Second Affiliated Hospital of Nanjing Medical University,Nanjing 210011,China;Department of Neurology,the Second Affiliated Hospital of Nanjing Medical University,Nanjing 210011,China)

机构地区：[1]南京医科大学第二附属医院内分泌科,南京210011 [2]南京医科大学第二附属医院神经内科,南京210011

出　　处：《中华内分泌代谢杂志》2023年第8期651-658,共8页Chinese Journal of Endocrinology and Metabolism

摘　　要：目的系统评价iGlarLixi治疗2型糖尿病(type 2 diabetes mellitus,T2DM)的疗效和安全性,为临床合理用药提供循证依据。方法计算机检索PubMed、Embase、Cochrane Library、Web of Science、Sinomed、CNKI、万方和维普数据库,收集比较iGlarLixi(试验组)和安慰剂或其他降糖药物(对照组)治疗T2DM疗效与安全性的随机对照试验(randomized controlled trials,RCTs),检索时限均为从建库至2022年8月。由2位评价员独立筛选文献,并从文献中提取资料和评价被纳入研究的偏倚风险后,采用RevMan5.4软件对数据进行meta分析。结果共纳入11项研究,6392例患者。Meta分析结果显示,疗效方面,iGlarLixi对比胰岛素和GLP-1RAs可以更好地降低患者HbA1C水平(胰岛素组WMD=-0.40,95%CI-0.54~-0.27,P<0.001;GLP-1RAs组WMD=-0.86,95%CI-1.05~-0.68,P<0.001)、提高HbA1C达标率(胰岛素组OR=2.83,95%CI 2.00~3.99,P<0.001;GLP-1RAs组OR=6.45,95%CI 4.81~8.64,P<0.001)、提高HbA1C达标且体重不增加率(胰岛素组OR=3.00,95%CI 2.43~3.71,P<0.001;GLP-1RAs组OR=2.67,95%CI 1.76~4.06,P<0.001)。iGlarLixi组与胰岛素组相比具有降低体重的优势,与GLP-1RAs组相比降低患者空腹血浆血糖(fasting plasma glucose,FPG)更有优势。安全性方面,iGlarLixi组低血糖事件发生率与胰岛素组无差异,但胃肠道不良事件发生率高于胰岛素组。与GLP-1RAs相比,胃肠道不良事件发生率无差异,但低血糖事件发生率iGlarLixi组较高。严重不良事件发生率与胰岛素组和GLP-1RAs组相比无差异(胰岛素组OR=0.94,95%CI 0.71~1.23,P=0.640;GLP-1RAs组OR=0.97,95%CI 0.61~1.52,P=0.880)。结论iGlarLixi具有良好的降糖作用,降低体重的作用优于胰岛素但劣于GLP-1RAs,严重不良事件发生率与胰岛素和GLP-1RAs组相比无明显差异,说明iGlarLixi有良好的耐受性和安全性,有良好的临床应用前景。Objective To systematically evaluate the efficacy and safety of iGlarLixi in the treatment of type 2 diabetes,providing evidence-based support for rational clinical medication.Methods A systematic review was conducted by retrieving articles from PubMed,Embase,Cochrane Library,Web of Science,Sinomed,CNKI,Wanfang,and VIP databases to collect randomized controlled trials comparing the efficacy and safety of iGlarLixi(intervention group)with placebo or other anti-hyperglycemic drugs(control group)in the treatment of type 2 diabetes.The search was conducted from the inception of the databases up to August 2022.Two reviewers independently screened the literature,extracted data,and assessed the risk of bias in the included studies.Meta-analysis was performed using RevMan 5.4 software.Results A total of 11 studies with 6392 patients were included in the meta-analysis.The results of the meta-analysis showed that in terms of efficacy,compared to insulin and GLP-1RAs,iGlarLixi demonstrated better reduction in patients′HbA1C levels(Insulin group WMD=-0.40,95%CI-0.54--0.27,P<0.001;GLP-1RAs group WMD=-0.86,95%CI-1.05--0.68,P<0.001),increased HbA1C target rate(Insulin group OR=2.83,95%CI 2.00-3.99,P<0.001;GLP-1RAs group OR=6.45,95%CI 4.81-8.64,P<0.001),increased HbA1C control rate without weight gain(Insulin group OR=3.00,95%CI 2.43-3.71,P<0.001;GLP-1RAs group OR=2.67,95%CI 1.76-4.06,P<0.001).Furthermore,iGlarLixi showed an advantage in weight reduction compared to the insulin group and demonstrated superior reduction in fasting plasma glucose compared to the GLP-1RAs group.In terms of safety,the incidence of hypoglycemic events in the iGlarLixi group was similar to that in the insulin group,but the incidence of gastrointestinal adverse events was higher than that in the insulin group.There was no difference in the incidence of gastrointestinal adverse events compared with GLP-1RAs,but the incidence of hypoglycemic events was higher in the iGlarLixi group.The incidence of serious adverse events was similar to that in the insu

关 键 词：糖尿病 2型 iGlarLixi 疗效 安全性 META分析 

分 类 号：R587.1[医药卫生—内分泌]